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U.S. Department of Health and Human Services

About FDA

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Romidepsin

On November 5, 2009, the U.S. Food and Drug Administration granted approval to romidepsin for injection (ISTODAX, Gloucester Pharmaceuticals Inc.) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.

The efficacy and safety of romidepsin were evaluated in two single-arm, multicenter, open label trials.  Efficacy was assessed in 167 patients with CTCL treated in the United States, Europe, and Australia.  Study 1 included 96 patients with CTCL who had received at least 1 prior systemic therapy. Study 2 included 71 patients with CTCL who received a median of 2 prior systemic therapies.  In both trials, patients could be treated until disease progression.  Overall response was evaluated according to a composite endpoint that included assessments of skin involvement, lymph node and visceral involvement, and Sézary cells.

The primary efficacy endpoint for both trials was the overall response rate (ORR) based on the investigator assessments, and defined as the proportion of patients with confirmed complete response (CR) or partial response (PR).  The ORRs in these two trials were similar (34 and 35% in Study 1 and Study 2, respectively) and CR rates were the same (6%).  The median response duration was 15 months in Study 1 and 11 months in Study 2. 

Safety data was available and evaluated in 185 patients with CTCL.  The most common adverse reactions in Study 1 were nausea, fatigue, infections, vomiting and anorexia.  The most common adverse reactions in Study 2 were nausea, fatigue, anemia, thrombocytopenia, ECG T-wave changes, neutropenia and lymphopenia.  Serious adverse reactions reported in > 2% of the patients in Study 1 were infection, sepsis, and pyrexia.  Serious adverse reactions reported in > 2% of the patients in Study 2 were infection, supraventricular arrhythmia, neutropenia, fatigue, edema, central line infection, ventricular arrhythmia, nausea, pyrexia, leukopenia, and thrombocytopenia.

The recommended dose and schedule of romidepsin is 14 mg/m2 intravenously over 4 hours on days 1, 8 and 15 of a 28-day cycle. 

Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at 

http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022393lbl.pdf